Omparison was utilised to model binomial information for sensitivity analyses.ResultsStudies
Omparison was applied to model binomial data for sensitivity analyses.ResultsStudies and patient characteristicsSeven RCTs had been integrated inside the final evaluation. The literature search identified six RCTs that met the trial selection criteria (Attachment two), and had been utilised for the pairwise evaluation. The GetGoal-S trial [20] was added to consist of one particular study presenting proof on lixisenatide NOP Receptor/ORL1 supplier compared with placebo (Figure 1).The seven RCTs (n=3,301 patients) compared the efficacy and security of: lixisenatide versus placebo; exenatide versus placebo or insulin glargine; and insulin glargine versus placebo or NPH-insulin in adult sufferers with T2DM requiring a second- or third-line treatment agent owing to inadequate glycaemic control (Table 1). Sufferers in all studies continued taking metformin plus sulphonylurea when exenatide, lixisenatide or insulin therapy was initiated. Baseline demographic traits per therapy groups are summarized by study in Table 1. Mean age (range 55.09.8 years), mean HbA1c (range 7.9.7 ) and mean body mass index (BMI; 30.14.six kgm2) were related across studies. The proportion of female sufferers was 29.79.0 ; mean illness duration was 7.6.9 years and mean weight was 82.301.4 kg.Hypoglycaemia, weight modifications and HbA1cThe incidence of hypoglycaemia and weight alter is summarized by study in Table two. The proportion of sufferers with confirmed hypoglycaemia (definitions by plasma glucose or blood glucose values differ slightly between studies [60 to 55 mgdL; 3.four to three.1 mmolL]) was larger with lixisenatide, exenatide and in-GMS German Healthcare Science 2014, Vol. 12, ISSN 1612-5Fournier et al.: Indirect comparison of lixisenatide versus neutral …Table 1: Baseline traits from the seven trials included for indirect OX2 Receptor list comparisonGMS German Healthcare Science 2014, Vol. 12, ISSN 1612-6Fournier et al.: Indirect comparison of lixisenatide versus neutral …sulin glargine compared with placebo, but equivalent among exenatide and insulin glargine. The incidence of confirmed hypoglycaemia was higher with NPH-insulin compared with insulin glargine (Table 2). Similar results were obtained for all round hypoglycaemia (Table two). Weight changes had been higher with lixisenatide (lower), exenatide (decrease) and insulin glargine (increase) compared with placebo, as well as with exenatide (lower) compared with insulin glargine (boost). Weight alterations with insulin glargine (boost) and NPH-insulin (boost) were related (Table 2). Changes in HbA1c are summarized in Table three. Baseline HbA1c parameters were comparable across studies. Greater alterations in HbA1c values have been observed with lixisenatide, exenatide and insulin glargine compared with placebo. Comparable adjustments in HbA1c parameters have been observed with exenatide compared with insulin glargine and with insulin glargine compared with NPH-insulin (Table 3).Table two: The incidence of hypoglycaemia and weight modifications by studyTreatment-emergent adverse eventsThe numbers of discontinuations resulting from treatmentemergent adverse events (TEAEs) were tiny in the various remedy arms from the studies (minimum 0.7 , maximum 9.six ) and no clear trends across compared remedies could possibly be observed by way of example, exenatide versus placebo: four.2 versus 5.1 [10] and 9.1 versus four.five [17] (Table three).Outcomes of indirect comparisonsHypoglycaemiaThere have been considerably fewer sufferers who skilled hypoglycaemia getting lixisenatide compared with NPHinsulin (OR: 0.38; 95 CI: 0.17, 0.85; RR: 0.56; 95 CI: 0.32,.